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Marker Therapeutics, Inc. (MRKR)

Q4 2016 Earnings Call· Wed, Mar 15, 2017

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Transcript

Operator

Operator

Good afternoon and welcome to the TapImmune Year-end 2016 Business Update Conference Call. All participants will be listen-only-mode. [Operator Instructions]. After today's presentation, there will be an opportunity to ask questions. [Operator Instructions]. Please note this event is being recorded. I would now like to turn the conference over to Joshua Drumm. Please go ahead.

Joshua Drumm

Analyst

Thank you, Gary. Good afternoon and welcome to the TapImmune fourth quarter and year end 2016 investor conference call. Before turning the call over to management, I would like to make the following remarks concerning forward-looking statements. During the call, we will make forward-looking statements within the meaning set forth in the Private Securities Litigation Reform Act of 1995. These statements are subject to certain risks and uncertainties, and include but are not limited to any of the following. Any statements other than the statements of historical fact regarding management's expectations, beliefs, goals and plans about the Company's prospects including its clinical studies for its cancer vaccine candidates' advancement of its PolyStart technology, future financial position, future revenues and projected costs and market acceptance of the Company's product candidates. More specifically forward-looking statements include any statements about our clinical development plans, and the timing cost and results thereof, projections as to the Company's future spending and cash position, expectations as to the timing and nature of anticipated regulatory action, possible product licensing or other business development transactions, any commercial plans and expectations, market projections for our product candidates and expectations as to manufacturing and product component cost. Our actual results may differ materially from these projections or estimates due to a variety of important factors including but not limited to uncertainties related to clinical development, regulatory approvals and commercialization. These risks are described in greater detail in TapImmune's filings with the Securities and Exchange Commission, which are available at tapimmune.com as well as the SEC's website. TapImmune may not actually achieve the goals or plans described in these forward-looking statements and investors should not place undue reliance on these statements. Please note that TapImmune does not intend to update forward-looking statements except as required by law. At this time, it is now my pleasure to turn the call over to Dr. Glynn Wilson, Chief Executive Officer of TapImmune. Glynn please go ahead.

Glynn Wilson

Analyst

Thanks Josh and good afternoon everyone and thank you for joining us on our first quarterly investor conference call. We plan to host similar corporate update calls to enhance transparency and highlight our progress, as we and our clinical partners advance our cancer vaccine candidates through multiple clinical trials. We'll also discuss our strategy for continuing to build shareholder value through successful clinical execution, as well as the upcoming milestone that we expect to achieve in the near and long-term. Joining me on the call today is Dr. John Bonfiglio, our President and Chief Operating Officer, who will provide further detail on our current and planned clinical programs. First, I'd like to provide a general overview of our Company for those who may be new to TapImmune and highlight some of our recent achievements. TapImmune is a clinical stage immune-oncology company that is distinguished by our focus on women's cancers. We are currently advancing two T-cell vaccine candidates in multiple phase 2 and phase 1/2a clinical trials. Our initial focus is on addressing the unmet need in women's cancers, specifically ovarian breast cancers, where reoccurrence rates are high following surgery and initial therapy. The time to reoccurrence is relatively short for these cancers, and survival prognosis is extremely poor once the cancer recurs. These cancers also tend to be resistant to most immunotherapies, which is why we believe we have a significant opportunity to improve the lives of these patients. Our novel immunotherapies are design to target both tumors and metastatic disease for intractable ovarian and breast cancer. Our T-cell cancer vaccine technology is engineered to overcome deficiencies of earlier approaches in this field. Our vaccines have the potential to be a powerful standalone therapy against a variety of cancers, as well as the central component of the leading combination…

John Bonfiglio

Analyst

Thanks Glynn, and thank all of you for calling in today. Our lead vaccine candidate, TPIV 200 is currently being evaluated in three Phase 2 clinical studies, with the fourth study planned to initiate in 2017. The completed Phase 1 study of TPIV 200 that enrolled a Phase 2/3 ovarian parasenile [ph] and fallopian tube cancer patients show that 95% of the valuable patients generated robust immune responses of TPIV 200, and a 100% of those patients demonstrated T-cell responses lasting six months or longer. These positive results were published in the journal of clinical oncology, and has led to significant partnerships for the Phase 2 development. First study is being done in collaboration with AstraZeneca, sponsored by Memorial Sloan Kettering-Cancer Center. It's a single arm Phase 2 study that will enroll 40 women with Platinum-resistant ovarian cancer, who either progressed while receiving platinum based therapy such as carbo platinum or cyst [ph] platinum or have had disease progression within six months of completing platinum therapy. This study is evaluating TPIV 200 plus the adjuvant GMCSF in combination with AstraZeneca’s PD-L1 checkpoint inhibitor, durvalumab. TPIV 200 is administered as an intradermal injection once per monthly cycle, and durvalumab is given intravenously twice per cycle. The treatment period for the combination therapy is six weeks, six cycles and after which patients continue on durvalumab alone for another six cycles. Patients are then followed up until disease regression. Primary endpoint for this study's overall response rate is defined by the resist criteria, but certain predefined deviations from resist will be permitted if it's determined that patients are benefitting from the therapy. The enrollment began in May of 2016 and is more than 50% completed. We have anticipated the study report for an interim analysis and in second half of this year. We…

Glynn Wilson

Analyst

Thanks John. For financial details, I'll direct the listeners to our Form 10-K filing which was actually filed today. There you can find our full financial results for the fourth quarter and for the full year 2016. On this call and on future quarterly update calls, I will just provide some of the key highlights, such as time of uplisting to the NASDAQ capital markets, we raised around $9 million to add to the cash we already have in hand, and that gives us sufficient cash to execute our programs this year. Before I open it up for Q&A, let me summarize on upcoming milestones. 2017 is shaping up to be another landmark year for TapImmune, driven by business and commercial execution. We expect solid clinical progress to be the primary value driver for the Company, and we are looking forward to several upcoming catalysts as we focus on advancing our clinical pipeline as efficiently as possible. Our goal is to complete Phase 2 proof-of-concept studies for TPIV200, three of which are currently enrolling patients. As we've mentioned, we have surpassed 50% enrollment in our Memorial Sloan Kettering sponsored Phase 2 combination study with AstraZenica's checkpoint inhibitor and we expect to report results of an interim analysis in the second half of this year. For TapImmune's sponsored study TPIV200 for treating triple negative breast cancer, we anticipate completing enrollment by the year end with top-line results expected sometime in 2018. Furthermore, Mayo clinic has announced plans to commence two Department of Defense funded studies of our two vaccine candidates, one in triple negative breast cancer and the other in ductal carcinoma in situ later this year. We will also move TPIV110 into our HER2/neu positive breast cancer study as soon as possible once our amended IND is accepted. In addition,…

Operator

Operator

[Operator Instructions] The first question comes from Gary Anderson with Micro Cap Research. Please go ahead.

Gary Anderson

Analyst

Hello, Glynn and John. Thanks for the update and congratulations on having four different Phase 2 studies in progress with world class partners. I don’t know if I've ever seen a company with a market cap under $40 million that have that. There might be one out there. If there is I haven’t seen it yet. So congratulations on that. I was wondering if you could talk a little bit more about PolyStart, because I think that's very exciting technology, and I think I read somewhere, where you had already done a preclinical study or some trail at Mayo Clinic towards the development of an improved small pox vaccine. Can you talk about that earlier study on PolyStart and what it revealed?

Glynn Wilson

Analyst

Sure. Gary, it's Gylnn Wilson here. And thanks for the question. We get the comments about our market cap at lot of the time, and you are absolutely right. For a company that has four Phase 2 clinicals, our market cap is extremely low. But we see that as a great opportunity for new investors and the existing shareholders to join us and buy stock. With respect to PolyStart; PolyStart is an exciting technology and its received two patents or patent allowances, one in July last year and one last month, and it covers the -- the PolyStart portion is -- you know in high school biology one DNA makes one RNA makes one protein? Well in PolyStart, it's one DNA makes one RNA, makes at least four proteins. So you're getting multiple initiation sites for the translation into peptides or proteins. So it gives a bigger signal for a DNA vector that can be used as a vaccine technology. PolyStart is one component and it's collaboratively [ph] used as an alternative code on for the initiation, than is conventional. The second part of the structure is the way you encode for you antigens and you can mix and match antigens. You can use the same antigens that you're using as peptides and use this as a booster strategy. And so we think it's got enormous potential involved, oncology NFX disease. We have very strong patent position, which will go out to 2034. The proof-of-concept to PolyStart was done in collaboration with Mayo Clinic, using vaccines RS peptides that if you like is just a smallpox vaccine. We know that those peptides on their own could protect mice against a lethal dose of smallpox. So it's a potential vaccine. But we know that by putting and coding the DNA for those peptides in PolyStart, and then transfecting cells and then exposing those cells to a vaccine, those cells could be killed. So in other words the signal from PolyStart was coming out to the surface of those cells. We decided for commercial reasons that we were not going to pursue a smallpox vaccine commercially, but if there's a spree of the intro into a whole area of viral disease and potential for other viral indications.

Operator

Operator

[Operator Instructions] Showing no further questions. This concludes our question-and-answer session. I would like to turn the conference back over to Glynn Wilson for any closing remarks.

Glynn Wilson

Analyst

Yes, I'd just like to thank everybody for joining us today. We look forward to speaking with you again soon. Please visit our website at www.tapimmune.com where we try to keep that as up to date as possible on our progress and we welcome your input in the future. Thank you.

Operator

Operator

The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.